This invention relates to the field of low voltage electrical signal measurement devices and in particular, to the design of a hand-held sub-microvolt electrical signal measurement device. While the invention is described with particular emphasis to its use with auditory screening applications, those skilled in the art will recognize the wider applicability of the inventive principles such as vibration monitoring, gas monitoring, blood analysis, and alcohol intoximeters, such as disclosed hereinafter.
Test equipment capable of accurately measuring low voltage electrical signals in the sub-microvolt range has a wide range of applications from the monitoring of bioelectric signals in a human body, such as those found in the auditory system, to vibration monitoring and the measurement of electrical signals from chemical reactions such as found in alcohol intoximeters, more commonly referred to as breathalyzers. Low voltage electrical signals in the sub-microvolt range can be extremely difficult to detect, as often the signal noise levels and interference present can mask the desired signals. Handheld test equipment, in which numerous electrical circuits are packaged in close proximity, is particularly susceptible to such signal noise and interference. However, many of the applications in which the measurement of low-voltage electrical signals in the sub-microvolt range is required would benefit greatly from the use of portable, self-contained, hand-held test instruments.
For example, universal neonatal auditory screening programs have expanded greatly because of improved auditory measurement capability, improved rehabilitation strategies, increased awareness of the dramatic benefits of early intervention for hearing impaired babies, and changes in governmental policies. Current neonatal auditory screening approaches, however, do not account adequately for the many different types and degrees of auditory abnormalities that are encountered with present screening approaches. Because of this, individual screening tests based on a single measurement can be influenced negatively by interaction among various independent auditory abnormalities.
Current screening approaches have not considered adequately the entire screening program including: (i) physical characteristics of the measurement device i.e., portability, physical size and ease of use, (ii) operational characteristics of the device i.e., battery life, amount of record storage, required operating training, etc. and/or (iii) program logistics i.e., retesting mechanisms, referral mechanisms, record processing, patient tracking, report writing, and other practical aspects. These factors can interact negatively to increase the total cost of an auditory screening program, including the primary economic cost of screening and testing, the secondary economic cost of additional testing, and non-economic costs such as parental anxiety incurred when provided with incorrect information.
These costs, both actual and human, can be reduced by reducing the cost per test, reducing the false positive rate, and resolving false positive screening results at the bedside prior to hospital discharge. The cost per screening can be reduced with a dedicated device optimized for screening in any location and enhanced to allow effective operation by minimally trained personnel. The performance characteristic of the device of our invention includes reduced measurement time, the ability to operate and configure without an external computer, the ability to integrate and interpret all test results, the ability to store a large number of test results, long battery life, and bi-directional wireless transfer of data to and from external devices.
False positive results can be reduced in two ways. First, the initial screening test performance can be improved with enhanced signal processing, more efficient test parameters, and by combining different types of tests. Second, false positive rates also can be reduced by providing a mechanism for resolving an initial screening test failure at the bedside at the time of the initial screening. This capability is provided through the availability of an automated screening auditory brainstem response (ABR) test capability provided by the same device. Secondly, operational processes of a screening program can be improved through the use of several onboard computer based expert systems. These computer based expert systems provide improved automatic interpretation of single test results, automatic interpretation of multiple test results, and improved referral processes through the matching of local referral sources with various test outcomes, such as a referral to a specific type of follow-up, whether it be a pediatrician, audiologist, otolaryngologist, or a nurse. The device disclosed hereinafter integrates in a single, hand-held device, a single stimulus transducer, a single processor and a single software application for otoacoustic emission (OAE) and ABR testing.
An auditory abnormality is not a single, clearly defined entity with a single cause, a single referral source and a single intervention strategy. The peripheral auditory system has three separate divisions, the external ear, the middle ear, and the sensorineural portion consisting of the inner ear or cochlea, and the eight cranial nerves. Abnormalities can and do exist independently in all three divisions and these individual abnormalities require different intervention and treatment. Prior art physical and operational characteristics of devices and their influences on program logistics can interact negatively to increase the total cost of an auditory screening program. The primary economic cost is the cost of each screening test though this is not the only economic cost. A screening test failure is called a “refer” and usually is resolved with an expensive full diagnostic test scheduled several weeks after hospital discharge, resulting in significant economic cost. A substantial portion of these costs is unnecessary if the screening false positive rate is high. Non economic costs include parental anxiety for false positive screening results, unfavorable professional perception of program effectiveness for programs with high false positive rates and even inappropriate professional intervention because of misleading screening results.
The invention of multiple measurements into a single hand-held instrument allows for very important new functionality not available with existing neonatal auditory screening devices. This functionality includes (1) detection of common external and middle ear abnormalities; (2) the detection of less common sensorineural hearing loss associated with outer hair cell abnormalities, and (3) the detection of even less common sensorineural hearing loss associated with inner hair cell or auditory nerve abnormality. Moreover, the device disclosed hereinafter has the potential to improve the accuracy and reliability of OAE measurements, to allow for optimal interpretation of both the OAE and ABR results, and to improve the referral process.
Attempts have been made in the past to provide the capabilities provided by the present invention. In particular, U.S. Pat. Nos. 5,601,091 ('091) and 5,916,174 ('174) disclose audio screening apparatus which purport to provide a hand-held portable screening device. However, the screening device disclosed in those patents is used in conjunction with a conventional computer, and requires a docking station for full application use. In no way does the disclosure of either patent provide a hand-held device that can be used independently of any other computer. That is to say, the invention disclosed hereinafter provides a device of significantly reduced size i.e., hand-held, which is capable of providing OAE and ABR testing. It can be operated in a stand-alone mode, independently of any other computer connection, if desired. The device includes a patient database, with names, and full graphic display capability. The device also preferably is provided with a wireless infrared and an RS 232 connection port to provide output directly to printers or to a larger database where such is required. The '174 and '091 patents also operate on a linear averaging method to remove background noise. While such a method works well for its intended purposes, use of a linear averaging method is time consuming.
Accordingly, there is a need for portable, hand-held test equipment capable of accurately measuring low voltage electrical signals in the sub-microvolt range, and which is capable of providing improved signal reliability in a reduced time frame using an on-board processor to access and store information in an associated memory storage device.